Surgical C-arm systems recalled for missing warning label and spacer
Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with missing critical safety components (warning label and radiation-protection spacer). No illnesses or injuries have been reported, but the missing components present a risk of harm to surgical personnel and patients.
Plain-English summary
Philips North America is recalling Zenition 50 & 70 Mobile Surgery C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands. These systems were delivered without a warning label and without the Source-to-Skin Distance Spacer (Tube-spacer), a critical safety component.
The Source-to-Skin Distance Spacer helps maintain proper distance and provides radiation protection during surgical procedures. The missing warning label prevents users from accessing critical safety information about device operation.
Affected facilities in these territories that have received these systems should contact Philips North America regarding the missing components and take appropriate action to ensure proper device configuration before use.
The recalled product
- Product
- Zenition 50 & 70 Mobile Surgery C-arm
- Manufacturer
- Philips North America
Distribution
Part of a larger recall action
This product is one of 6 recalled by Philips North America under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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